Philips has become aware of a potential issue with Philips Interventional Hemodynamic Application R1.2.X, R1.3.0 and R1.3.1, where synchronization of pressure wave data received from two devices, the Intellivue X3 and Functional Measurement Patient Interface Module (FM-PIM) may not be correct. There might be a delay of the FM-PIM data with respect to the Intellivue X3 data which is not constant in time. When this occurs, the calculation of measurements will be affected, specifically the IFR (Instantaneous Wave-Free Ratio) and FFR (Fractional Flow Reserve) values. Recall Start Date: May 3, 2024
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